Research & Database Committee, ISDE & International Esodata Study Group - Research Program
IESG: International Esodata Study Group
ISDE: International Society for Diseases of the Esophagus
RD Committee: Research & Database Committee
PA Subcommittee: Publication & Audit Subcommittee
RDF: Research Data File
The Research & Database Committee (RD Committee) of the ISDE aims to facilitate access to the data for the participants of the International Esodata Study Group for the purposes of participant-led research with analyses performed at investigators’ institutions.
This initiative will be overseen by the Publication & Audit Subcommittee (PA Subcommittee) of the RD Committee, and will be guided by three overarching principles: 1) facilitating International Esodata Study Group (IESG) participant research, 2) ensuring research output of the highest quality, and 3) protecting Esodata and participant data, as well as patient privacy.
To accomplish this aim, the RD Committee (through the PA Subcommittee) will provide de-identified and quality checked Esodata to its database participant investigators for research purposes. The de-identified data will be provided in the form of Research Data Files (RDFs) derived from the Esodata under the supervision of the Database Administrator.
2.The International Esodata Study Group Research Process
There will be three sequential phases: i) Research Proposal Submission and Assessment, ii) RDF-based Data Analysis, and iii) Dissemination of RDF-based Research.
2.1Phase I – Research Proposal Submission and Assessment
Each year the PA Subcommittee will invite contributors to the Esodata database to submit short detailed research proposals addressing a research question aiming to obtain data for the analysis and publication from the Esodata database. In 2019 two research project will be selected for Esodata study. Following the initiation of the two primary studies, the PA committee will consider a theme-based application process that will potentially involve single or multiple Esodata contributing centers. Once the process of study allocation has been assessed, the PA committee will consider increasing the frequency of number of projects.
The (detailed) study proposals have to be submitted using the prototype application form of the International Esodata Study Group.
The chairs of the PA Subcommittee will collect all research applications and will make a proposal to the other members of the Subcommittee on the most reasonable allocation to the different applicants. The plenary Subcommittee will take a final decision (by simple majority). During this allocation process. The total number of patients enrolled in the Esodata database by each of the applying institutes will be one of many issues taken into account although the quality of the study proposal will remain paramount. A member of the IESG can only submit a research proposal, if he/she:
Has entered data covering at least two years.
Is still an active member, i.e. has updated his/her Esodata entry completely not longer than two months before;
Has been open to be audited upon request of the PA Subcommittee and if a local audit process has taken place it had an appropriate outcome;
The primary investigator is an active member of the ISDE;
The applying institution has paid all Esodata fees relevant at the time of application.
The successful investigators will be charged what is considered a reasonable fee (in first cycle: $2,500) to cover the costs for creating and handling the specific dataset by the Esodata Administrative Staff. At the present time, payment will be made into an account designated by the ISDE.
The chairs will make an updated register available for all members with a transparent overview of all previous Esodata publications and all research projects that have been submitted and accepted or rejected. This will increase transparency and limit the risk of duplication. The PA Subcommittee will encourage groups to work together on a research project if they have submitted similar requests during an application period.
In the beginning, during each ‘cycle’ not more than three study projects will be allocated (later on this number might be increased, after the required infrastructure has been installed and successfully tested and the Esodata Administrative Staff has demonstrated a capability of supporting additional studies). No single center will be awarded more than one study that requires active analysis. Any prior project must have been completed (i.e. published), before a specific center is eligible for a new research proposal. Failure to publish would count against the group.
The original dataset, required for each specific research project, will be made available to the principle investigator under the strict conditions as outlined in the Esodata User Agreement that the dataset can only be used for that specific project.
If the above rule is violated, the R&D Committee in conjunction with the PA Subcommittee will inform the specific member and may put forward a range of sanctions including taking steps to ensure the sanctioned unit destroys the data and does not publish any manuscript utilizing Esodata data.
2.2 Phase II: RDF-based Data Analysis
Principal Investigators in each center carrying out an Esodata study must sign the Esodata Study Agreement.
The analysis will be conducted at the investigators’ institution(s) according to the approved research design. The PA subcommittee must be notified about any material changes to the approved analysis plan that are proposed by the investigator(s), which may necessitate additional review and approval.
After receiving their RDF and as per the agreement, investigators will be required to submit progress reports to the PA subcommittee at least once every four months. Data analysis and production of a manuscript must be completed within twelve months of receiving the data. It is understood that submission of a manuscript may need to be delayed until the project is accepted for meeting presentation.
The PA subcommittee must be informed of changes to the original statistical analysis plan and in particular changes affecting the bio-statistics resources available to the investigative team, which will require PA subcommittee review and approval.
Investigators may consult with Chair(s) of the PA subcommittee at any time in case of questions related to the research project.
2.3 Phase III: Dissemination of RDF-based Research
Investigators will be expected to disseminate their RDF-based research results in the form of scientific research abstracts and manuscripts.
Before submission any abstract or publication needs approval by the (chairs of the) PA subcommittee and the (chair of the) R&D committee. For this (dis)approval a 1-week timeline is recommended. This process will ensure that outcomes being published using Esodata do not directly contradict previous publications using similar Esodata sets. For this purpose all previous publications of the IESG will be permanently available on the Esodata website.
Authorship includes the persons named on the study proposal and in case of collaborative projects can include members of other centers.
At the top of each abstract and each publication it should be explicitly stated that the work was performed “on behalf of the International Esodata Study Group" and an acknowledgment in the manuscript will list all contributing Esodata centers as well as their surgical leads.
Each institute of the IESG will have at least one co-author on each paper listed as collaborators (IESG). This will ensure PubMed indexing of all members and acknowledge the input of all institutions.
3. Additional rules for access to Esodata
A principal investigator requesting access to the Esodata must be a participant in the IESG and a current member of the ISDE.
By requesting access to the Esodata database the principal investigator implicitly accepts the rules as described in the Esodata User Agreement.
The principal investigator will hold the primary scientific roles on the approved RDF research, including actual research effort, eventual authorship, and other related responsibilities.
The principal investigator must inform the PA subcommittee of any additional investigators joining the project research team after its launch.
A principal investigator can have only one approved RDF-based study in which he or she is principal investigator at any given time, where active means ‘before formal submission of manuscript for publication’.
A principal investigator can be a co-investigator on other projects.
A research proposal should request only the data fields that are pertinent to the research aim of the proposal. The PA subcommittee will not approve broad download requests that are not justified.
The data provided to the investigator may be used only in conjunction with the approved project – typically one abstract and one manuscript.
Centers that identify an opportunity for an additional analysis related to their primary project can reapply to carry out such additional analysis.
The RDF will not include any information that could identify Esodata participants (surgeons, other physicians, or institutions) corresponding to any patient record provided.
The RDF may not be used to link to other sources of medical data.
The PA subcommittee will base its decision to approve or not approve a research proposal predominantly on the proposed research question and study analysis plan, but also will consider the research team strengths.
One of the factors that the PA subcommittee will balance when evaluating research proposals is the need to make the best use of available resources for processing requests. For example, the subcommittee will reserve the right to reject feasible and scientifically sound proposals if it has previously approved a similar proposal on the same topic.
Similarly, if the PA subcommittee receives multiple highly related and overlapping proposals within a short time frame, it may deny the later proposal, or it could attempt to bring investigative teams together for jointly conducted research.
Access to the provided RDF file should be restricted to the principal investigator and the statistics/analysis investigator. Investigators may not copy and distribute the RFD files outside their investigative teams.
All investigators must destroy all copies of the provided RDF file and any derived patient-level data files within 1 year after acceptance of the research for publication in final form. However, before destroying this file, the final data file on which their analysis was performed should be sent to the central IESG office, where it will be stored to allow for the potential of auditing.